Prepare for Your Diabetes Care

Kaiser Permanente

Status: Active, not recruiting

Conditions: Aging; Patient Activation; Type 2 Diabetes Mellitus With Hypoglycemia

Treatments: Behavioral: Prepare for Your Diabetes Care; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05263310

R01AG068133 (U.S. NIH Grant/Contract)

IRB-1635322

Details and patient eligibility

About

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

Full description

In this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible Kaiser Permanente Northern California members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%). Participants randomly allocated to the intervention arm will view the Prepare for Your Diabetes Care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an Action Plan handout. Participants randomly allocated to the control arm will continue with usual care. All participants will complete baseline, 6-month, and 12-month surveys. The hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Enrollment: 600 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 75 years
• Type 2 diabetes with last measured HbA1c ≤ 8.0%
• Currently prescribed insulin and/or SUs
• Kaiser Permanente Northern California member

Exclusion criteria

• Unable to communicate in English
• Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits
• Excluded by their primary care provider

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Educational Video and Action Plan handout

Experimental group

Description:

Patients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout. This program will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps with the participant's primary care provider.

Treatment:

Behavioral: Prepare for Your Diabetes Care

Usual Care

Active Comparator group

Description:

Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys

Treatment:

Behavioral: Usual Care